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Engineer, Process Validation

Location: 

Baltimore (Bayview), MD, US, 21224


Those who join Emergent BioSolutions feel a sense of ownership about their future. You will excel in an environment characterized by respect, innovation and growth opportunities. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect life.

JOB SUMMARY

The Manufacturing Sciences and Technology (MS&T) Engineer position is responsible for leading process and technology transfer of one or more processes into a cGMP single use drug substance manufacturing facility. This position conducts, plans and leads tech transfer of processes into manufacturing, as well as collaboration and execution of process validation activities. This role includes preparing and reviewing of tech transfer and validation documentation. This position reports into MS&T Leadership at the Emergent Bayview manufacturing facility.

 

ESSENTIAL FUNCTIONS

  • Conduct, plan and lead tech transfer of one or more processes into manufacturing
  • Perform statistical analyses, and compare manufacturing batches and evaluate process performance
  • Support execution of Continued Process Verification strategy with MS&T team
  • Author and review technology transfer and validation documentation (including run summaries, reports and client presentations)
  • Develop, edit, review and sign cGMP documentation
  • Provide technical support for writing of project proposals, including development of process flow diagrams from process descriptions and development of a bill of materials
  • Support technical writing needs of the MS&T group
  • Select, integrate, evaluate and become subject matter experts of process equipment
  • Support acceptance testing and training on capital equipment
  • Support all MS&T team goals including covering other pipeline projects as necessary to achieve MS&T team goals
  • Develop protocols, execute and report experiments that determine evaluation of key and critical process parameters
  • Travel for person-in-plant (or lab) runs as required for process transfer and troubleshooting
  • Evaluate incoming processes for operability and develop risk assessment plans
  • Responsible for coordination of technical activities on assigned projects
  • Determine equipment requirements and capital expenditure budgets for projects
  • Independently perform review of process control parameters and testing protocols
  • Represents EBS to external customers, at conferences and/or organizations such as ISPE, PDA or ASME
  • The above statements are intended to describe the general nature of work performed by those in this job.  It is not an exhaustive list of all duties, and other duties may be assigned.

 

MINIMUM EDUCATION, EXPERIENCE, SKILLS

  • Bachelor of Science degree in an engineering discipline with 4+ years of biologics drug substance manufacturing or development experience
  • Strong leadership skills; high level of personal/departmental accountability and responsibility.
  • Biologics manufacturing and/or technology transfer experience in one or more of the following areas:
    • Antibody therapeutics manufacturing
    • Viral or non-viral vaccine manufacturing
    • Microbial protein expression
  • Hands-on biologics expression of vaccines and/or therapeutics in industry
  • Ability to work collaboratively in multi-disciplinary teams
  • Excellent leadership, presentation, computer, and communication skills.
  • Experience using statistics software for process evaluation
  • Proficient with desktop software and basic programming experience
  • Experience with SAP or Equivalent ERP system
  • Experimental design experience
  • Experience with receiving and evaluating technology transfer data, development of bills of materials and evaluation of cGMP manufacturing suitability
  • Experience with writing SOPs, batch records, production protocols, deviation assessments, and technical reports
  • Experience with cGMP and/or EU regulations for biologics manufacturing
  • Experience with identifying, operating and evaluating process equipment

 

Preferred Qualifications:

  • Master’s degree in an engineering discipline or equivalent with 4+ years of process experience
  • Ability to operate process and analytical equipment and other instruments
  • Familiarity with analytical methodologies for determining protein structure, concentration, and purity
  • Chemical engineering and/or molecular biology background

 

 

PHYSICAL/MENTAL DEMANDS AND WORK ENVIRONMENT CHARACTERISTICS

  • The physical/mental demands are representative of those that must be met by an individual to successfully perform the essential functions of the job.
  • The work environment characteristics described here are representative of those an individual would encounter while performing the essential functions of the job.
  • Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Emergent BioSolutions is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, Protected Veteran status, sexual orientation, or any other characteristic protected by federal, state or local law.

Information submitted will be used by Emergent BioSolutions for activities related to your prospective employment. Emergent BioSolutions respects your privacy and any use of the information submitted will be subject to the terms of our Privacy Policy .

Emergent BioSolutions does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on Emergent BioSolutions’ approved agency list. Unsolicited resumes or candidate information submitted to Emergent BioSolutions by search/recruiting agencies not already on Emergent BioSolutions’ approved agency list shall become the property of Emergent BioSolutions and if the candidate is subsequently hired by Emergent BioSolutions, Emergent BioSolutions shall not owe any fee to the submitting agency.

ABOUT EMERGENT

Protecting and Enhancing 1 billion lives by 2030 focuses our energy to improve the quality of life for individuals around the world, giving them the opportunity to experience the fullness of life.

Our drive towards this vision informs all of our actions—whether it is our approach to product development, manufacturing, encouraging employee health and wellness or giving back to the community—we strive every day to achieve this shared goal.

WE BELIEVE IN OUR VALUES

  • Stand shoulder to shoulder no matter what
    • We combine our best thinking and communicate openly to support each other.
  • Break through thinking
    • We take smart risks, pursue innovation and challenge ourselves to constantly improve.
  • Own it always
    • Every person at Emergent is engaged and accountable for delivering on our commitments.
  • Compete where it counts
    • We set the right goals and respect each other as we conquer them together.